Events

Rappel de Device Recall Wound Closure Tray

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Customed, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    60753
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1261-2012
  • Date de mise en oeuvre de l'événement
    2011-12-08
  • Date de publication de l'événement
    2012-03-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106428
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    General surgery tray (kit) - Product Code LRO
  • Cause
    The firm has determined that there is a possibility that packaging seals may be compromised. the issue could result in an injury to the patient due to product contamination or loss of sterility condition.
  • Action
    Customed Inc sent an Urgent Medical Device Recall letter dated December 8, 2011 to distributors via e-mail; then by certified (return and receipt) mail. The letter identified the product, description of problem, and actions to be taken. The letter included the following instructions: 1. Product should be removed from sale (Quarantine them) and cease distribution. Products affected shall NOT be used. 2. Return the enclosed acknowledgement form to Customed, Inc. Recall Coordinator whether or not the consignee has affected products. 3. If products has been futher distributed, sub-recall products - It is extremely important to notify your customers of this action by including a copy of this leller along with your formal notification. Please, instruct your customer to follow your directions for credit/replacemenl if they purchased the product from you. For qucstions. contact Cuslomed, Inc. Recall Coordinator at 787-622-5151 Ext. 7510.

Device

Device Recall Wound Closure Tray
  • Modèle / numéro de série
    lot# 111010011, 110122973, 111020329, 111020330, 111030537, 111041095, 111051223, 111051457, 111071876, 111082178
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution - including Florida and Puerto Rico.
  • Description du dispositif
    Wound Closure Tray I, catalog# 900-063
  • Manufacturer
    Customed, Inc

Manufacturer

Customed, Inc
  • Adresse du fabricant
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Société-mère du fabricant (2017)
    Customed Inc
  • Source
    USFDA